BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3251175 · Received July 29, 2013

    Report

    Report Number
    2122870-2013-00644
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SUBSTRATE VALVE AND NOTICED LOOSE SUBSTRATE CAP FITTINGS. THE FSE TIGHTENED THE FITTINGS. THE FSE PERFORMED SYSTEM CHECK, 50 REPETITIONS OF LUMIBLANK TO TEST SUBSTRATE DELIVERY, CALIBRATED TROPONIN ASSAY, AND COMPLETED ALL LEVELS OF QUALITY CONTROL (QC). SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A MALFUNCTION OF THE SUBSTRATE DELIVERY SYSTEM IS THE LIKELY CAUSE OF THIS EVENT. IMPROPER DISPENSING OF SUBSTRATE INTO THE REACTION VESSELS (RVS) MAY LEAD TO DECREASED RELATIVE LIGHT UNITS (RLU'S) VALUES AND THE NO VALUE/IND FLAGGED PATIENT RESULTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2013-00645 AND 2122870-2013-00646

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO VALUE AND IND (INDETERMINATE) FLAGGED TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR MULTIPLE PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. THE CUSTOMER STATED THE NON-NUMERICAL RESULTS WERE NOT REPORTED FROM THE LABORATORY AS THESE WERE NOT ACTUAL PATIENT VALUES. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THE PATIENTS' SAMPLES WERE RETESTED ON THE LABORATORY'S ALTERNATE ACCESS 2 ANALYZER; ACTUAL RESULTS WERE NOT SUPPLIED. THE CUSTOMER PERFORMED A REAGENT LOT-TO-LOT COMPARISON OF PATIENT SAMPLES FOR HUMAN CHORIONIC GONADOTROPIN (HCG) AND THE RESULTS WERE NOT REPRODUCIBLE AND OUTSIDE THE ACCEPTABLE LIMITS. ALL LEVELS OF QUALITY CONTROL (QC) RECOVERED WITHIN THE LABORATORY'S ESTABLISHED RANGES. CALIBRATION PASSED WITH ACCEPTABLE PERCENT COEFFICIENT OF VARIATION (%CV). SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT ONE OF THREE REFERENCING THE PATIENT ON THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353583 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1